The need to create a good barrier contraceptive and anti-infective device has never been greater. The world population is constantly on the rise, so are the unplanned and unwanted pregnancies. STD, especially AIDS, are widespread in many parts of the world. Many attempts at the barrier methods have been made to counter this trend, some to certain success, but none has been able to be truly effective in both contraception and disease prevention.
The problems with the familiar condom are well known. It depends on the rigidity of the unreliable penis to stay in place. Furthermore it only covers the body of the penis and not the base, therefore unable to prevent diseases, such as herpes and warts, through the external genital, anal or oral contact. In addition, it depends on the male partner's willingness to use it. It is also not user friendly. Unrolling it in dim lighting often ends up in the wrong direction, and its strangulating pressure decreases the tactile sensation of the penis.
Female condoms thus provide viable alternatives to male condoms.
U.S. Pat. No. 5,094,250 (FIG. 1a) to Hessel describes a thin wall tubular device with a closed end and an open end. It has an inner ring at the closed end positioned at the cervix and an outer ring at the open end positioned at the introitus. The device only partially shields the external genitalia and it does not seal up the introitus. Therefore it does not prevent infections through direct contact of external genitalia or the exchange of body fluid. Furthermore, it is more expensive to produce than a regular condom.
To address the above issues of preventing exchange of body fluid and shielding the external genitalia to achieve better contraception and disease prevention during coitus, U.S. Pat. No. 5,269,320 (FIG. 1b) to Hunnicutt describes a rubber female condom with an extended shield at the open end. The shield covers the external genitalia, pudendum, and is secured in place by an adhesive. The shield may be formed as part of a panty or men's brief. The tubular portion is provided in a compacted, folded state, and together with the shield portion, it is covered by releasing paper on both sides.
U.S. Pat. No. 4,898,184 (FIG. 1c) to Skurkovich et al describes a similar female condom made of rubber latex, but with greater shield area held in place by weak adhesive or straps around the genitalia.
U.S. Pat. No. 5,515,862 (FIG. 1d) to Artsi describes yet another similar female condom with an even larger shield that is sealingly attached to or integrally formed with the open end, said shield having six well defined regions which together form a continuous, seamless surface surrounding the open end, the surface having a continuous outer edge. An adhesive is applied close to, and around the entirety of the outer edge beyond the pubic hairline to resist seepage of fluid during coitus. The tubular portion is provided in the folded manner like a concertina, as seen in the invention of Hunnicutt.
All the three aforementioned female condoms with the adhering shield are made of a thin soft water-impermeable material, for instance rubber latex or other biologically acceptable plastic films, such as polyurethane, polyethylene, polypropylene, polyester, nylon, polyvinyl chloride, bioplastics, nitrile and others. As the shield portion has a plane which is perpendicular or at an angle to the tubular portion, the constructions of these female condoms are complicated, let alone the difficulty in the application of adhesive onto the flimsy shield, as the tubular portion is situated at the centre of the shield. If rubber latex is used as described in the construction in the aforementioned prior art of FIG. 1b and 1c, a complex molding process and adhesive application will be needed, so the cost of production will be high. On the other hand, if a thin flexible membranous film is used, one would not be able to create a “continuous, seamless surface” for the shield as described by Artsi, and membranous film will be difficult to handle due to its flimsiness. For example, to fold the thin membranous tubular portion into a concertina as described by Artsi would be technically difficult.
There is therefore a need for female condoms with adhering shield that can be manufactured at a low cost and can be easy to handle, while providing a secured barrier for both internal and external genitalia to effectively prevent unplanned pregnancies and transmission of STD during coitus.